Effect of Donepezil on Smoking

Browse trials for

• Smoking 325

Keywords

• Non-treatment seeking smokers, reporting consumption of at least
• 10 cigarettes per day for at least the past 6 months

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 30 is below the median of 117 across 250 interventional studies indexed under Smoking.

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.

Study arms

• Placebo comparator
  Placebo

  Participants are instructed to take one placebo pill every night before going to bed with a glass of water for 28 days.

  Drug: Placebo

• Experimental
  Donepezil

  Participants are instructed to take one 5mg pill (donepezil HCL \[Aricept®\]) every night before going to bed with a glass of water for 28 days.

  Drug: Donepezil

Interventions

• DrugDonepezil

  Also known as: Aricept

• DrugPlacebo

Primary outcomes

1. Change From Baseline in True Positives on the 3-Back Level of the Letter-N-Back Neurocognitive Task at Day 28 (i.e., Week 4)

   Neurocognitive task performance was assessed during baseline and each testing day (Day 7, 14, 21, and 28) using computerized tasks. Working memory was assessed with the Letter-N-back task.

   Time frame: Baseline and Day 28

2. Change From Baseline in Discriminability on the Penn Continuous Performance Neurocognitive Task at Day 28 (i.e., Week 4)

   Sustained attention was assessed with the Penn Continuous Performance Task (P-CPT). The primary outcome measure was the change from Baseline in discriminability (score) on the P-CPT at Day 28. The discriminability score is the mathematical difference between the total correct (i.e., true positives and correct non-responses) and incorrect (i.e., errors of commission and omission) responses to a series of stimuli presented during the P-CPT. The unit of measure is number of correct responses less the number of incorrect responses. A higher discriminability score at a single time point indicates a better performance on the P-CPT. A positive change in discriminability score between Baseline and Day 28 indicates improved performance over time. In its purest mathematical sense, the discriminability measure is a difference of difference scores and therefore is without scale limits, that is, there are no minimum or maximum values one could theoretically obtain.

   Time frame: Baseline and Day 28

Secondary outcomes

1. Change From Baseline in Smoking Behavior (i.e., Cigarettes Per Day) at Day 28 (i.e., Week 4)

   At each visit, smoking rate (i.e., cigarettes per day) was assessed using standard Timeline Followback methods. Weekly averages were computed to assess group differences in changes in smoking behavior from Baseline to Day 28.

   Time frame: Baseline and Day 28

2. Summary Side Effect Score at Day 28 (i.e., Week 4)

   A 38-item self-report measure of the side effects associated with Donepezil (e.g., nausea) was administered to all participants at observation and testing days through Day 28. For each item, side effect severity was rated on a 4-point scale (0 = not present, 1 = mild, 2 = moderate, 3 = severe). The side effect summary score from the measure collected at Day 28 was considered the dependent measure because Day 28 is when the medication reached steady state. The side effect summary score was calculated by taking the mean score (i.e., sum of all 38 items \[each item rated on a scale 0-3\] divided by 38) of the measure from each participant at Day 28, adding the means, and then dividing the sum of the means by the number of participants within each group. A higher summary score indicates a higher general incidence rate and severity of side effects.

   Time frame: Day 28

Baseline characteristics